Obesity

Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity — A Phase 2 Trial

N Engl J MedPublished Randomised controlled trial

Authors' conclusion

In this phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 diabetes.

Study context

Population
Adults with obesity (obesity cohort: 465; female 63%, mean age 47.9 years, mean BMI 37.9) and with obesity and T2D (obesity-diabetes cohort: 127; female 42%, mean age 55.1 years, mean BMI 36.5)
Participants
592 adults2 cohorts
Comparison
Once-monthly maridebart cafraglutide (MariTide) at various doses/schedules vs placebo
Primary endpoint
Percent change in body weight from baseline
Follow-up
Week 52
Methodological detailsphase 2, double-blind, placebo-controlled, dose-ranging, 11 groups as two cohorts
  • Phase 2
  • Double-blind
  • Placebo-controlled
  • Dose-ranging
  • 11 groups as two cohorts

Primary result

As reported in the abstract

Mean percent change in body weight (treatment policy estimand) · baseline to week 52

Obesity cohort: maridebart cafraglutide, range across doses

−12.3% (95% CI, −15.0 to −9.7) to −16.2% (95% CI, −18.9 to −13.5)

Obesity cohort: placebo

−2.5%

95% CI −4.2 to −0.7

Obesity-diabetes cohort: maridebart cafraglutide, range across doses

−8.4% (95% CI, −11.0 to −5.7) to −12.3% (95% CI, −15.3 to −9.2)

Obesity-diabetes cohort: placebo

−1.7%

95% CI −2.9 to −0.6

Further findings

Mean change in HbA1c, obesity-diabetes cohort · treatment policy estimand — Placebo
mean 0.1 percentage points
Mean change in HbA1c, obesity-diabetes cohort — Maridebart cafraglutide (range across groups)
−1.2 to −1.6 percentage points

Safety

GI adverse events were common with maridebart cafraglutide, although less frequent with dose escalation and a lower starting dose
No unexpected safety signals emerged

Original publication

Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity — A Phase 2 Trial. N Engl J Med. Published 23 June 2025. doi:10.1056/nejmoa2504214

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